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Metabolic Side-effects for Second-generation Antipsychotics

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by The University of Hong Kong.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01280396
First received: January 19, 2011
Last updated: January 28, 2011
Last verified: January 2011
  Purpose

Second-generation antipsychotics (SGAs), including clozapine, are commonly used nowadays as treatment for psychosis. There are increasing concerns about their related metabolic side-effects over weight gain, risks to cause glucose intolerance and hyperlipidemia, and a specific condition known as metabolic syndrome. All these side-effects might be associated with the increased risk of cardiovascular diseases and diabetes mellitus.

This study is to analyze the simple physical measurements (weight and height) and venous blood tests (for fasting blood glucose and lipid) results collected routinely since 2008 (recommended by the local hospital authority as a territory-wide "SGAs Monitoring Program") from those outpatients receiving SGAs (amisulpride, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone and ziprasidone) and/or clozapine, at a local psychiatric outpatient clinic in Hong Kong. The investigators hypothesized that there should be differential risks on metabolic side-effects amongst these SGAs.


Condition
Mental Disorders

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Metabolic Side-effects in Patients Receiving Clozapine and Second-generation Antipsychotics in an Outpatient Clinic

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Estimated Enrollment: 372
Study Start Date: November 2010
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
SGAs
patients receiving SGAs

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Out-patients in a public psychiatric out-patient centre
Criteria

Inclusion Criteria:

  • was ≥18 years of age
  • out-patients
  • had received any one of these antipsychotics: aripiprazole, amisulpride, clozapine, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone
  • consented to provide physical measurements and venous blood samples

Exclusion Criteria:

  • not consented to provide venous blood samples and/or physical measurement
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01280396

Contacts
Contact: Albert Kar Kin Chung, MBBS +852-22556226 chungkka@hku.hk

Locations
Hong Kong
Western Psychiatric Centre Recruiting
Hong Kong, Hong Kong, 00000
Contact: Albert Kar Kin Chung, MBBS    +852-22556226    chungkka@hku.hk   
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Albert Kar Kin Chung, MBBS Department of Psychiatry, Queen Mary Hospital
  More Information

Responsible Party: Chung Kar Kin Albert, Department of Psychiatry, Queen Mary Hospital
ClinicalTrials.gov Identifier: NCT01280396     History of Changes
Other Study ID Numbers: HKCTR-1205 
Study First Received: January 19, 2011
Last Updated: January 28, 2011

Keywords provided by The University of Hong Kong:
metabolic
SGAs
clozapine

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Clozapine
Antipsychotic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
GABA Antagonists
GABA Agents

ClinicalTrials.gov processed this record on February 24, 2017